- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01266837
Open Label, Single Arm Trial to Characterize Patients With Metastatic RCC Treated With Everolimus After Failure of the First VEGF-targeted Therapy (MARC-2) (MARC-2)
November 10, 2017 updated by: iOMEDICO AG
An Open Label, Single Arm Trial to Characterize Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of the First VEGF-targeted Therapy
A single arm, open-label, multi-center phase IV clinical trial for patients with metastatic renal cell carcinoma, who have progressed on or after the first VEGF-targeted therapy.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 12203
- Charite Campus Benjamin Franklin
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Dresden, Germany, 01307
- Klinik und Poliklinik für Urologie , Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
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Erlangen, Germany, 91054
- Urologie - Waldkrankenhaus St. Marien
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Essen, Germany, 45122
- Klinik für Innere Medizin (Tumorforschung), Universitätsklinikum Essen
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Hannover, Germany, 30625
- Zentrum Innere Medizin, Medizinische Hochschule Hannover
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Homburg, Germany, 66421
- Klinik für Urologie und Kinderurologie, Universitätsklinikum des Saarlandes
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Jena, Germany, 07743
- Klinik für Urologie, Universitätsklinikum Jena
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Nürnberg, Germany, 90419
- 5. Medizinische Klinik, Klinikum Nürnberg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provide written informed consent
- Aged 18 years and above
- Histologically or cytologically confirmed predominantly clear cell renal cell carcinoma
- Metastatic disease documented by CT or MRI (histological confirmation not mandatory but wishful)
- Patients with or without nephrectomy (partial or total)
- Patients with at least one measurable lesion at baseline according to RECIST criteria 1.1
- Failure of exactly one prior VEGFR-TKI therapy (e.g. sunitinib, sorafenib, pazopanib) for metastatic renal cell carcinoma
- ECOG 0-2
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥75,000/μL
- Absolute neutrophil count ≥1,5x109/l
- Serum creatinine < 2.5 x ULN
- Liver function: Serum bilirubin ≤ 1.5 x ULN, AST or ALT ≤ 2.5 x ULN. Patients with suspected liver metastasis: AST and ALT ≤ 5x ULN
- Able to swallow the study drug whole as a tablet
- Expected life expectancy of at least 6 months
- Women of childbearing potential must have had a negative serum pregnancy test within 14 days prior to the administration of the study treatment or must have a documented condition that prohibits pregnancy (e.g. hysterectomy, post-menopausal).
Exclusion Criteria:
- Patients who have received >1 prior VEGFR-TKI therapy or prior therapy with bevacizumab +/- interferon.
- VEGFR-TKI therapy within 14 days prior to start of study drug
- Patients who have previously received systemic mTOR inhibitors (sirolimus, temsirolimus, everolimus).
- Patients with a known hypersensitivity to everolimus or other rapamycin (sirolimus, temsirolimus) or to its excipients.
- Any condition which, in the opinion of the investigator, would preclude participation in this trial
- Patients within 4 weeks post-major surgery (e.g., intra-thoracic, intra-abdominal or intrapelvic), open biopsy, or significant traumatic injury to avoid wound healing complications. Minor procedures and percutaneous biopsies or placement of vascular access device require 7 days prior to study entry.
- Patients who had radiation therapy within 4 weeks prior to start of study treatment. Palliative radiotherapy to bone lesions within 2 weeks prior to study treatment start.
- Patients in anticipation of the need for major surgical procedure during the course of the study.
- Patients with a serious non-healing wound, ulcer, or bone fracture.
- Patients with a history of seizure(s) not controlled with standard medical therapy.
History or clinical evidence of central nervous system (CNS) metastases. Subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible:
- are asymptomatic and,
- have had no evidence of active CNS metastases for ≥ 3 months prior to enrolment (inactive/controlled CNS metastases are allowed) and,
- have no requirement for steroids or enzyme-inducing anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin)
- Patients receiving chronic systemic treatment with corticosteroids (dose of > 10 mg/day methylprednisone equivalent) or another immunosuppressive agent. Inhaled and topical steroids are acceptable.
- Poorly controlled diabetes as defined by fasting serum glucose >2.0 x ULN.
- Impaired liver function classified as Child-Pugh class C.
- Active (acute or chronic) or uncontrolled infection of bacterial, mycotic or viral genesis.
- Liver disease such as chronic active hepatitis or chronic persistent hepatitis.
- Patients with a known history of HIV seropositivity.
- Patients with active bleeding disorders.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions within the past 12 months that could affect their participation in the study such as cardiac angioplasty or stenting, unstable angina pectoris, symptomatic peripheral vascular disease, symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction ≤ 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia, any disorders that impair the ability to evaluate the patient or for the patient to complete the study.
- Patients who have a history of another primary malignancy and off treatment for ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix or breast, and localized cancer of the bladder (T1) and prostate (T1 - T2).
- Female patients who are pregnant or breast feeding.
- Men and women of reproductive potential who are not using highly effective birth control methods. Oral contraceptives for female patients and barrier contraceptives are not acceptable. For definition of highly effective birth control methods please refer to section 12.3.6 of this protocol.
- Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start.
- Patients unwilling or unable to comply with the protocol.
- Exclusion criteria for MRI: intracorporal metal (e.g. incompatible heart valves, pacemakers), contrast media allergy, claustrophobia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: single arm
Treatment with Everolimus
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10 mg p.o once daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of patients progression free 6 months after start of study treatment
Time Frame: 2 years after LPI
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2 years after LPI
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relation between biomarkers and clinical benefit (response, stable disease and progression/ no clinical benefit) of patients
Time Frame: 2 years after LPI
|
2 years after LPI
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Michael Staehler, Dr. med, Ludwig-Maximilians-University Munich, Hospital Grosshadern
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
September 26, 2017
Study Completion (Actual)
October 31, 2017
Study Registration Dates
First Submitted
December 23, 2010
First Submitted That Met QC Criteria
December 23, 2010
First Posted (Estimate)
December 24, 2010
Study Record Updates
Last Update Posted (Actual)
November 14, 2017
Last Update Submitted That Met QC Criteria
November 10, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Everolimus
Other Study ID Numbers
- CRAD001LDE36T
- 2010-021370-11 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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